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Kidney Transplant for HIV-Infected Patients in Renal Failure

2014-07-24 14:35:11 | BioPortfolio

Summary

This study will examine the safety and effectiveness of renal (kidney) transplantation for HIV-infected patients with end-stage renal disease (kidney failure). Although kidney transplant is the best treatment for most causes of kidney failure, people infected with HIV are not offered this procedure because the immunosuppressive drugs (drugs that suppress immune function) required to prevent organ rejection could further impair the patient's already weakened immune system. This study will use a regimen of immunosuppressants designed to complement treatment for patients taking highly active antiretroviral therapy (HAART).

HIV-infected patients between 18 and 60 years of age with renal failure who have not had any opportunistic infections for 5 years may be eligible for this study. Candidates will be screened with a medical history, physical examination, and blood and urine tests.

Before the transplant procedure, participants will undergo additional tests and procedures, including blood studies, 24-hour urine collection, infectious disease consultation, tuberculin skin test, PAP smear for women, chest X-ray, brain and hip MRI studies and DEXA-scan to evaluate bone density. In addition, patients may undergo leukapheresis to obtain white blood cells for study. For this procedure, whole blood is drawn through a needle in an arm vein and passed through a cell separator machine. The white cells are collected for removal, and the rest of the blood is returned to the body through the same needle or another needle in the other arm.

When a donor organ becomes available for transplant, the patient will receive three anti-rejection drugs-cyclosporine, mycophenolate mofetil and prednisone-to prevent organ rejection. Immediately after the surgery, HAART drugs will be stopped for 7 days until stable levels of the immune suppressants can be achieved. Then, HAART will be re-started and all medications will be adjusted to achieve adequate blood levels. Patients must stay in the local area 60 days after discharge from the hospital for monitoring. Frequent blood samples will be taken to monitor kidney function, viral load and CD4+ T cell counts. Follow-up visits will then be scheduled monthly for the first 6 months after transplant, then every other month for 1 year. Kidney biopsies will be done at the end of the first month, after 6 months, and yearly for 5 years. For the biopsy, a special needle is used to remove a small piece of kidney tissue for microscopic examination. The biopsies and blood tests are done to evaluate the immune response to the transplanted organ and to study how HAART interacts with the immune suppressing drugs.

Description

Renal allotransplantation is the treatment of choice for most causes of end-stage renal disease (ESRD). However, successful transplantation is dependent on the use of potent immunosuppressive drugs to prevent immune mediated rejection of the transplanted organ. Patients who have become infected with the Human Immunodeficiency Virus (HIV) have an underlying immune deficit resulting primarily from the virus's affect on CD4+ T lymphocytes. Many of these individuals also develop ESRD. However, patients with HIV infection have been excluded from allotransplantation. This has been based on the premise that the immune suppression required for transplantation would adversely affect their already compromised immune system. Recently, the treatment of HIV infection has improved dramatically, particularly with the advent of protease inhibitors (PI) and their inclusion in highly active anti-retroviral therapy (HAART) protocols. Additionally, some immunosuppressant drugs have actually been shown to limit the replication and spread of HIV in vitro. Thus, the treatment of HIV associated ESRD with allotransplantation may be feasible.

This protocol is a pilot trial investigating the potential utility of renal transplantation to treat ESRD in patients infected with HIV. Ten patients with controlled HIV infection will receive renal allografts under an immunosuppressive regimen designed to complement HAART protocols. Immune system monitoring will be performed specifically to evaluate the effect of immunosuppressive drugs on the T cell function and viral burden of allograft recipients. The allograft will be periodically evaluated to assess the prevalence of disease recurrence or rejection. Pharmacokinetic evaluation will be performed to define the interactions between HAART and immunosuppressive drug regimens. Long-term outcome will be assessed at 1 and 5 years and compared to contemporaneous outcomes for non-infected patients receiving the standard of care. It is hoped that this protocol will suggest ways of providing HIV infected patients with renal replacement therapy without jeopardizing their control over their viral infection.

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Conditions

Chronic Kidney Failure

Intervention

immunosuppressive regimen designed to complement HAART

Location

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Bethesda
Maryland
United States
20892

Status

Completed

Source

National Institutes of Health Clinical Center (CC)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:35:11-0400

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Medical and Biotech [MESH] Definitions

A severe irreversible decline in the ability of kidneys to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal failure, either acute (KIDNEY FAILURE, ACUTE) or chronic (KIDNEY FAILURE, CHRONIC), requires HEMODIALYSIS.

The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.

Conditions in which the KIDNEYS perform below the normal level for more than three months. Chronic kidney insufficiency is classified by five stages according to the decline in GLOMERULAR FILTRATION RATE and the degree of kidney damage (as measured by the level of PROTEINURIA). The most severe form is the end-stage renal disease (CHRONIC KIDNEY FAILURE). (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002)

An hereditary hemolytic uremic syndrome associated with variations in the gene that encodes COMPLEMENT FACTOR H, or the related proteins CFHR1 and CFHR3. Disease often progresses to CHRONIC KIDNEY FAILURE without the prodromal symptoms of ENTEROCOLITIS and DIARRHEA that characterize typical hemolytic uremic syndrome.

A complication of kidney diseases characterized by cell death involving KIDNEY PAPILLA in the KIDNEY MEDULLA. Damages to this area may hinder the kidney to concentrate urine resulting in POLYURIA. Sloughed off necrotic tissue may block KIDNEY PELVIS or URETER. Necrosis of multiple renal papillae can lead to KIDNEY FAILURE.

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